RegeneRx Receives Notice of Acceptance for Patent in Australia For Treatment of Neural Injury with Thymosin Beta 4.

ROCKVILLE, Md., Jan. 9, 2017 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that it has received a Notice of Acceptance for a patent from the Australian Patent Office for the use of Thymosin beta 4 (Tβ4), the active pharmaceutical ingredient in the RegeneRx's proprietary drug candidate, RGN-352, to myelinate damaged neurons or axons (brain nerve cells). Myelination is a process of forming a myelin sheath around a nerve to allow nerve impulses to move more efficiently and is vitally important to healthy central nervous system functioning.

The research supporting this patent was conducted by Dr. Michael Chopp's research team at the Henry Ford Hospital System in Detroit, MI and has been published in numerous neurological scientific journals.

The patent expiry is March 26, 2030, not including any potential extensions.

"This patent continues to expand the scope of potential use of RGN-352, our systemic formulation of Tβ4, in patients with neural injury and disease. The remyelination properties of Tβ4 found by Dr. Chopp and his team in their animal models suggests considerable potential for the use of Tβ4 in major disorders such as multiple sclerosis, as well as any other condition or disease that is associated with demyelination," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.

RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (Tβ4) and its constituent fragments, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and has patents and patent applications covering its products in many countries throughout the world. RGN-259, the Company's Tβ4-based ophthalmic drug candidate, has been designated an orphan drug in the U.S. for the treatment of neurotrophic keratopathy (NK). In March 2016, RegeneRx, through its U.S joint venture, ReGenTree LLC, completed a 317-patient Phase 2b/3 clinical trial in patients with dry eye syndrome (DES). The dry eye trial results were announced in May 2016 and ReGenTree has subsequently begun enrollment in a second Phase 3 DES trial in approximately ~500 patients. The Company is simultaneously conducting a 46-patient Phase 3 clinical trial in patients with NK. RGN-259 is also being developed in patients with dry eye syndrome in Asia through RegeneRx's two Asian partnerships. RGN-352, the Company's Tβ4-based injectable formulation, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and repair cardiac damage resulting from heart attacks and central nervous system tissue damage associated disorders such as multiple sclerosis and traumatic injuries such as stroke. For additional information about RegeneRx please visit www.regenerx.com.

Forward-Looking Statements

Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. There can be no assurance that any notices or patents issued by any government patent authority in any country, or licenses held by the Company, or patent applications filed by the Company, including this most recent Notice of Acceptance in Australia, or any current or future clinical trials will result in approved products or future value. Please view these and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" section of the annual report on Form 10-K for the year ended December 31, 2015, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.